Eyekon Medical, Inc.: FDA clearances and approvals
Eyekon Medical, Inc. has 1 FDA 510(k) clearance (first 2026, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 94 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 94 |
Review time against the same product codes
Since 2017, Eyekon Medical, Inc.'s cleared 510(k)s took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQL | Intraocular Lens | 1 | 0 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 1 | 1 |
Review panels
- Ophthalmic (2)
Most recent Eyekon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261312 | Temporary Keratoprosthesis (QuickSet TKP) | MLP | 2026-07-24 | 94 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880072 | PMA | MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL | 1989-09-22 |
Recalls
openFDA lists no recalls under a recalling firm named Eyekon Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Eyekon Medical, Inc.'s product codes (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MLP)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MLP)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MLP)
Frequently asked questions
How many FDA 510(k) clearances does Eyekon Medical, Inc. have?
Eyekon Medical, Inc. has 1 FDA 510(k) clearance (first 2026, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Eyekon Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Eyekon Medical, Inc.'s cleared 510(k)s is 94 days.
What devices does Eyekon Medical, Inc. make?
Its most frequent FDA product codes are HQL (Intraocular Lens, 1); MLP (Keratoprosthesis, Temporary Implant, Surgical Use, 1).
Has Eyekon Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Eyekon Medical, Inc. Related entities may recall under other names.
Next steps
- See all 1 Eyekon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Eyekon Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.